Decreasing the intraluminal pressure has a inhibiting effect on the rebleeding incidence.
ID
Bron
Verkorte titel
Aandoening
Colonic diverticular bleeding
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Evaluation of the efficacy of polyethylene glycol versus psyllium fiber in a randomized controlled trial to prevent rebleeding and readmission in patients hospitalized for colonic diverticular bleeding.
Achtergrond van het onderzoek
Colonic diverticular bleeding is one of the most common causes of lower gastrointestinal bleeding. The results of previous studies show that repeated rebleeding occurs in approximately 10 - 20% within the first year. No consensus exists as to the best treatment to prevent rebleeding. Treatment options range from lifestyle advise such as increased intake of dietary fiber, supplementation of fibers or laxatives.
This study aims to evaluate the efficacy of laxatives (polyethylene glycol) versus supplementation of fibers on the incidence of rebleeding in patients hospitalized for colonic diverticula bleeding.
Single-center, randomized clinical trial.
Doel van het onderzoek
Decreasing the intraluminal pressure has a inhibiting effect on the rebleeding incidence.
Onderzoeksopzet
Screening period (-2 days, Visit 0), Week 0 (visit 1), Week 6 (Visit 2), Week 12 (visit 3).
Onderzoeksproduct en/of interventie
Polyethylene glycol or Psyllium fiber
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients between the ages of 18 and 85 years old;
- Patients who are hospitalized for bleeding diverticular disease in the Elisabeth-Tweesteden Ziekenhuis (ETZ);
- Patients with diverticular disease based on colonoscopy <5 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Other bleeding diseases of the colon requiring medicinal treatment such as IBD or infection;
- Patients hypersensitive to macrogol or psyllium;
- Surgical treatment following initial episode of bleeding diverticular disease;
- Patients using polyethylene glycol or psyllium fiber regularly, more than twice daily;
- Patients who are pregnant, lactating or planning pregnancy while enrolled in the study;
- Patients who are unsuitable for inclusion in the study in the opinion of the investigator for any reason that may compromise the subject's safety or confound data interpretation.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9454 |
| CCMO | NL71286.028.19 |
| OMON | NL-OMON52735 |